Samsung medical center
Seoul, South Korea
NCT Number: NCT05742438
This is a prospective randomized controlled trial. Investigators aimed to compare the effect of three different anesthetic adjuvants (continuous infusion of lidocaine or dexmedetomidine, intrathecal morphine injection) on the biomarker for cancer recurrence and metastasis.
Patients undergoing elective colorectal cancer surgery will be randomly allocated to three parallel arms and the biomarkers for cancer recurrence and metastasis, inflammation, and immune response will be compared. And we will compare the clinical outcomes in the three method.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Seoul, South Korea
Perioperative period is critical in determining the risk of postoperative metastatic disease. Surgical damage and related stress response could suppress cell-mediated immunity and facilitate malignant cell survival, motility, invasion and proliferation. Increasing evidence supported that the continuous infusion of lidocaine or dexmedetomidine, or intrathecal morphine were associated with the reduction of postoperative pain and opioid consumption and improved the quality of recovery.
Also, they were reported to decrease perioperative inflammatory responses and preserve immune response which is known to be critical in anti-metastatic process during perioperative period. However, no comparison was conducted among these anesthetic adjuvants. Thus, Investigators try to evaluate the effect on the biomarkers and clinical outcomes in the three methods.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous intravenous infusion of lidocaine
Other names: Lidocaine
Continuous intravenous infusion of dexmedetomidine
Other names: Precedex
intrathecal morphine injection
Other names: Morphine
Time frame: 1 hour after surgery
plasma Matrix metalloproteinase-9
Time frame: at the induction of anesthesia
plasma Matrix metalloproteinase-9, on the morning of postoperative day 1
Time frame: at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery
plasma Matrix metalloproteinase-2
Time frame: at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery
Interleukin-6
Time frame: at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery
vascular endothelial growth factor
Time frame: at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery
CD3+CD4+ (helper T cells), CD3+CD8+ (cytotoxic T cells), CD3-CD16+CD56+ (Natural killer(NK) cells), CD3+CD16+CD56+ NK T cell, CD39+, CD73+, CD39+CD73+ expressions on CD4+ and CD8+ T cells
Time frame: within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery)
Pain severity with numeric rating scale for postoperative pain, the value range (0~10), a higher score means more painful
Time frame: within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery)
morphine equivalent unit of opioid consumption
Time frame: within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery)
the requirement of rescue antiemetic
Time frame: within 7 days after the surgery
from the end of surgery to the time of first flatus
Time frame: Until the discharge (up to postoperative day 30)
from the end of surgery to patient discharge
Time frame: during the night of surgery
pulse oximetry value < 92% or the need for reintubation.
Time frame: within 7 days after the surgery
need for in-and-out catheterization or reinsertion of an indwelling urinary catheter during the hospital stay after the original urinary catheter was removed, and re-operation
Time frame: within 3 and 1 day after surgery, respectively
orthostatic headache and itching sensation
Time frame: within 1 month after surgery and discharge, respectively
Reoperation was defined as any surgical procedure performed under general or regional anaesthesia for treatment of complications related to the initial operation within 30 days after surgery.
Readmission was defined as any hospital admission occurring after discharge within 30 days from the index surgery, specifically related to postoperative complications or management associated with the initial surgical procedure.
Samsung Medical Center
Other
Effect of Dexmedetomidine Infusion, Lidocaine Infusion, and Intrathecal Morphine Injection on Biomarker for Perioperative Stress and Immune Response, and Cancer Progression and Metastasis in Colorectal Cancer Surgery
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